India: Issues Concerning Patenting Inventions Relating To Plants, Animals And Microorganisms

The Patent Act, 1970 specifies what are not considered inventions under Section 3. Section 3(b) of the Act earlier recited: 'What are not inventions - an invention the primary or intended use of which would be contrary to law or morality or injurious to public health;'

This definition was brief and the words tapered the scope of the section. An amendment was brought in 2002, to accommodate the TRIPS regulations. The amendment resulted in a new and more descriptive definition of the section. The section now reads -

'3(b) an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;' [Is not invention]

The Amendments:

TRIPS mainly aimed at excluding subject matter relating to medical methods, or those contrary to public order and morality, and subject matter covering plants and animals, and essentially biological processes from being patentable subject matter.

The amendments were hence made in 2002 to bring under the Act, the regulations of TRIPS and to extend the scope of the Act to protect plants, animals and human beings alike. Along with Section 3(b), Sections 3(h), 3(i), 3(j) and Section 3(p) were amended with a similar point of view.

According to Section 3(h), methods of agriculture or horticulture are not patented. Further, Section 3(i) prohibits patenting process used in medicine and treatments of human beings and animals, both either as part of treatment and for increasing their economic value or the economic value of their products.

Section 3(j) includes further provisions to prevent patenting of plants and animals as a whole or in part thereof. The Section further prevents patenting of 'biological processes for production or propagation of plants and animals'. However, micro-organisms are patentable subject matter.

Section 3(p) prohibits patenting of traditional knowledge.

Coming to the point where these sections are considered eco-friendly, it is important to note that all the above mentioned sections have a direct impact on the protection of bio diversity. The debate on Technology V. Bio diversity will always appear in the front row, and as always, a check on the use of technology is the only supportive argument.

The Seed Act 1966, the Bio-diversity Act, 2002, The Protection of Plant Variety and Farmer's Rights Act, 2001 are all laws brought forward to support the cause. For example, the Section 6 of the Biodiversity Act says- 'Application for intellectual property rights not to be made without approval of the National Biodiversity Authority'.

The Laws:

Laws that are in contrary to public order and morality have always faced criticism. Article 19 of the Indian Constitution holds any Act violating or hindering the operation of law an offence. In other words the main aim of any law is to bring order and to protect the moral and social values in the society.

The patent laws emphasize the need for novelty, non-obviousness, utility and the presence of a human intervention, when it comes to biological matter.

Plants and Patents:

Though "Bio-Diversity" is an 'all-inclusive' word, it is more often used as a synonym for "Plants and Animals"

Inventions that drastically affect both Plants and Animals are not patentable under the Section 3(b).

This however is not accepted without arguments that for more than one reason, people would want better technology. The need is as simple as the explanation for livelihood. Man depends on plants and animals in numerous ways and inventions that help better are always welcome. Be it the chemical preparation of weedicides and insecticides or the enormous saws that bring down gigantic trees, man wants it all. For example, US7520118 and EP1583434 are patents that are granted to machines that cut down plants. Genetically modified crops are also a big hit in the market.

In R.W.Emerson's words, a weed is a plant whose virtues have not yet been discovered. However, the general perceptions of weeds outweigh the good points about them. Where on one side one may argue about soil stability, a farmer would argue about the reduced crop quality.

Monsanto, an agricultural company tried to claim protection to its "Method for producing a transgeneric plant (with increased stress tolerance)" the application was rejected protection by India's Patent Office, and the same was upheld by the Intellectual Property Appellate Board on the grounds that the invention lacked inventive step.

Patents on Animals:

Dolly, the first cloned sheep was refused a patent in US. Though the creators succeeded in getting a patent on the process used, the USPTO refused the patent on Dolly (claiming actual cloned animals) and said – "Dolly's genetic identity to her donor parent renders her un-patentable"

It may be noted that microorganisms on the other hand are considered patentable subject matter even in India. In the matter of Diamond v. Anand Chakrabarty (a case in the US), the applicant had developed a bacterium capable of breaking down crude oil. The application was initially rejected on the ground that living things cannot be patented. However, the invention was considered on appeal and a patent was granted, making it the land mark judgment on patenting microorganisms.

Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, it was decided that deposits of microorganisms was to be made at an International Depositary Authority (IDA) on or before the filing date of the complete patent application. In India, Microbial Type Culture Collection and Gene Bank (MTCC) - Institute of Microbial Technology, Chandigarh and Microbial Culture Collection Centre (MCC), Pune are the IDAs.

Gatekeeper Patents:

Generally, most gene patents act as gatekeeper patents. Gatekeeper patents are patents that stop an invention from getting patented because the new technology or process relies on the existing technology or process. For example : Human Genome Sciences Inc. (HGS), obtained patent over a human gene CCR5 that was later identified to have key role in HIV infection. It was much later that the importance of the gene was understood and if the applicant desired, the patent on the gene could have hindered the research on AIDS and HIV.

A gene can qualify for a patent only if it is isolated and a change has been made in-vitro.

In conclusion, the laws in India are quite restrictive with respect to patenting of inventions concerning plants, animals and humans. While, such a restrictive approach may be good for the nation at present, if all the countries were to adopt similar approach, then research will be adversely affected, since patent protection (in other words monopoly) is most often the core incentive for researchers in the fields of science and technology.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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